G/LIC/N/2/KOR/41  
 
27 October 2020  
(20-7470) Page: 1/3 
Committee on Import Licensing  Original: English  
 
AGREEMENT ON IMPORT LICENSING PROCEDURES  
NOTIFICATION UNDER ARTICLE 5.1 TO 5.4 OF THE AGREEMENT1 
REPUBLIC OF KOREA 
The following notification dated 8 October 2020 , is being circulated at the request of the delegation 
of the Republic of Korea . 
 
 Category  Notification details  
1 Notifying Member  Republic of Korea  
2 Title of new 
legislation/procedure  Advanced Regenera tive Medicine and Advanced Biomedicine Safety 
and Support Act  
3 Date of Publication  27 August 2019 
4 Date of entry into force  28 August 2020 
5 Website link/Official 
publication of the new 
regulation/procedure  http://www.law.go.kr/LSW/lsSc.do?section=&menuId=1&subMenuI
d=15&tabMenuId=81&eventGubun=060101&query=%EC%B2%A8
%EB%8B%A8%EC%9E%AC%EC%83%9D%EC%9D%98%EB %A3%
8C+%EB%B0%8F+%EC%B2%A8%EB%8B%A8%EB%B0%94%EC
%9D%B4%EC%98%A4%EC%9D%98%EC%95%BD%ED%92%88+
%EC%95%88%EC%A0%84+%EB%B0%8F+%EC%A7%80%EC%9
B%90%EC%97%90+%EA%B4%80%ED%95%9C+%EB%B2%95%
EB%A5%A0#undefined    (In Korean language )  
6 Have you attached a copy of 
the regulation (PDF) to the 
Secretariat   Yes. ( Please attach a copy of the regulation to the notification ) 
 
 No. 
7 Type of notification   (a) New licensing regulation/procedure2; (please answer question 
8 to 14)  
 
 (b) Changes to a regulation/procedure which has been p reviously 
notified in document:  ______________ ;   ( please answer question 
15 and 16 ) 
8 List of products subject to 
licensing  3001.90.1010 , 3001.90.9020, 3002.11.0000, 3002.12.1000, 
3002.12.9021, 3002.12.9022, 3002.12.9040, 3002.12.9090, 
3002.13.9000, 3002.14.9000, 3002.15.0000, 3002.19.9000, 
3002.30.9000, 3002.90.1000, 3002.90.2000, 3002.90.3010, 
3002.90.3020, 3002.90.3090, 3002.90.4000, 3002.90.5000, 
3002.90.9000, 3003, 3004  
(Items related to advanced bio-medicine and human cells ) 
 
Imports may be carried out  under the following condition : Those 
who import advanced bio -medicine and human cells must obtain 
permission from the Ministry of Food and Drug Safety  (Regional  
Food and Drug Administration).  And t he importer can import the m 
after completing the standard customs clearance report to the Korea 
Pharmaceutical Traders Association  at each import.  
 
1 It is understood that the notifying Member has also completed its notification obligations under 
Article  1.4(a) and Article 8.2(b) regarding the relevant law/regulation/procedure notified for by filling this form 
in a full and complete manner.  
2 "New licensing regulation/procedure" is understood to refer to any newly introduced law, regulation or 
procedure, and those which are in force but being no tified for the first time to the Committee.  G/LIC/N/2/KOR/41  
 
- 2 - 
 
   Category  Notification details  
9 Nature of licensing  Automatic:  
 
Non-Automatic:  
10 Administrative 
purpose/measure being 
implemented  (a)  Protect public morals;  
(b)  Protect human, animal or plant life and health; protect 
environment;  
(c)  Collect trade statistics or market surveillance;  
(d)  Protection of patents, trademarks and copyrights, and 
the prevention of deceptive practices;  
(e)  Pursue obligations under the UN Charter and other 
international treaties ( i.e. CITES, Basel Convention, 
Rotterdam Convention, UNSC Resolutions etc.)  
(f)  Quota (including TRQ) administration;  
(g)  Regulate imports of arms, ammunition or fissionable 
materials and safeguard national security;  
(h)  Other: ______________ (please specify)  
11 Administrative body(ies) for  
submission of applications   Ministry/authority and Department: Ministry of Food and Drug 
Safety  
Address: 187, Osongsaengmyeong 2 -ro, Osong -eup, Heungdeok -gu, 
Cheongju -si, Chungcheongbuk -do, Republic of Korea , 28159  
Website: https://www.mfds.go.kr/eng/index.do   
Telephone: 82-43-719-3304] 
 
Ministry/authority and Department: Korea Pharmaceutical Traders 
Association  
Address: 33, Magokdong -ro, Gangdeo -gu, Seoul, Republic of Korea , 
07806  
Website: http://www.kpta.or.kr/eng/main/main.asp   
Telephone: 82-2-2162-8000 
12 Contact point for 
information on eligibility  Ministry/authority and Department: Ministry of Food and Drug 
Safety  
Address: 187, Osongsaengmyeong 2 -ro, Osong -eup, Heungdeok -gu, 
Cheongju -si, Chungcheongbuk -do, Republic of Korea , 28159  
Website: https://www.mfds.go.kr/eng/index.do   
Telephone: 82-43-719-3304] 
 
Ministry/authority and Department: Korea Pharmaceutical Traders 
Association  
Address: 33, Magokdong -ro, Gangdeo -gu, Seoul, Republic of Korea , 
07806  
Website: http://www.kpta.or.kr/eng/main/main.asp   
Telephone: 82-2-2162-8000 
13 Expected duration of 
licensing procedure  There is no related regulation  
14 A summary of the 
notification in one of the 
WTO official languages   The purpose of this Act is to contribute to the improvement of public  
health and quality of life by preparing a system for securing safety of 
advanced regenerative medicine and measures for innovation and 
practical use of technology, and by prescribing matters necessary for 
securing the quality, safety, effectiveness, and s upport for 
commercialization of advanced bio -medicine.  
Those who import advanced bio -medicine and human cells must 
obtain permission from the Ministry of Food and Drug Safety  
(Regional  Food and Drug Administration).  And t he importer can 
import the m after completing the standard customs clearance report 
to the Korea Pharmaceutical Traders Association  at each import.  
15 In the case of 7(b), please 
indicate the type of new 
change(s)  (a)  Termination  
(b)  Suspension  
(c)  Modification of specific details in existing  
procedures:  
 Product coverage;  
 Administrative purpose;  G/LIC/N/2/KOR/41  
 
- 3 - 
 
   Category  Notification details  
 Automatic or Non -automatic;  
 Duration of licensing;  
 Change the nature of quantity/value restriction;  
 Eligibility of applicants;  
 Contact information on eligibility;  
 Administrative body(ies) for submission of application;  
 Documentation requirements (including application form);  
 Period for Application;  
 Administrative body(ies) to issue licence;  
 Processing time for issuing licence;  
 Licence fee/administrative charge;  
 Deposit/advance payment and relevant conditions;  
 Appeal regulations/procedures;  
 Validity of licence;  
 Other conditions of licence (extension, transferability, 
penalty of non -use etc.);  
 Foreign exchange requirements;  
 Other:  __________ (please specify).  
 
16  Please elaborate the 
changes in detail (in one of 
the WTO official languages)   
__________